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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K170047
Device Name All-in-One Health Monitor, PC-303
Applicant
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou Tian'An Industry Town
Shenzhen,  CN 518054
Applicant Contact Jia Wang
Correspondent
Irc, LLC
7808 Rush Creek Dr.
Pasco,  WA  99301
Correspondent Contact Charles Mack
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DSH   DXN   FLL   NBW  
Date Received01/05/2017
Decision Date 09/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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